
All claims are based on a critically sized canine
proximal humerus defect model. It is unknown how results from the canine
model compare with clinical results in humans.
†Growth factor binding based on in vitro data of BMP-2
and VEGF. Data on file.
*FASTER THAN AUTOGRAFT: The accelerated rate of
healing of the PRO-DENSE® treated defects compared to those treated with
autograft is principally evident by the higher density bone (i.e., 170%
average increase in area fraction of new bone compared to autograft at
13 weeks) and superior average mechanical properties at 13 weeks. DENSER
THAN AUTOGRAFT: Histomorphometry reveals that the amount of newly
regenerated bone of the PRO-DENSE® injectable treated defects at 13
weeks demonstrated a statistically significant 170% average increase in
new bone formation versus defects treated with autograft. PRO-DENSE®
injectable new bone area fraction is on average 170% denser than
autograft at 13 weeks.
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